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Subject: Important Safety Information and New Prescribing Information for
the Erythropoiesis-Stimulating Agents, Aranesp(R) (darbepoetin alfa) and
EPREX(*) (epoetin alfa)
TORONTO, April 19 /CNW/ - The manufacturers of the
erythropoiesis-stimulating agents (ESAs), in consultation with Health Canada,
would like to inform you of updated safety information and pending label
changes regarding treatment with ESAs. Two ESAs, Aranesp(R) and EPREX, are
authorized for use in Canada. ESAs are drugs used to increase the production
of red blood cells and decrease the need for red blood cell transfusion. These
medicines may be used in patients with kidney failure or in patients with
cancer where the anemia is associated with chemotherapy.
As a result of these updates, EPREX is no longer approved for use in
patients with cancer who do not have anemia associated with chemotherapy.
Therefore, none of the ESAs are approved for use in this patient population.
In consultation with Health Canada, the Canadian prescribing information
for these medicines will be revised by the manufacturers to reflect the new
safety information listed in the box below. Patients are advised to contact
their doctor or pharmacist if they have any questions or concerns regarding
their current treatment with these medicines.
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- ESAs are drugs used to increase the production of red blood cells and
to decrease the need for red blood cell transfusion and the dose
should be gradually adjusted to achieve this goal. Hemoglobin levels
during ESA treatment should not be higher than 120 g/L. (May not be
applicable to all surgery patients, see below).
- Patients treated with EPREX before elective surgery should receive
antithrombotic treatment to avoid blood clots.
- In recent studies, a higher risk of death and serious cardiovascular
adverse events, such as stroke, heart attack, heart failure and blood
clots was seen in both cancer and chronic kidney disease patients
receiving ESAs to maintain a target hemoglobin level higher than
120 g/L.
- A higher risk of death was seen in patients with cancer and anemia
who were not receiving either radiation or chemotherapy and receiving
ESAs to maintain a target hemoglobin level of 120 g/L. ESAs are not
authorized for use in this patient population.
- Progression of tumour growth in patients with head and neck cancer
receiving radiation therapy only, occurred sooner in patients who
were also being treated with ESAs to a target hemoglobin level of
greater than 120 g/L.
- Increased death was seen in patients with metastatic breast cancer
receiving chemotherapy, who were also being treated with ESAs to a
target hemoglobin level of greater than 120 g/L.
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Several new medical studies, have described new risks associated with the
use of ESAs. These risks include cardiovascular problems, such as heart
attack, heart failure, stroke, blood clots or death, as well as decreased
survival in patients with cancer due to worsening of their cancer. ESAs are
not authorized for use in patients with cancer who do not have anemia
associated with chemotherapy. All patients should be monitored to ensure that
their red blood cell levels do not exceed 120 g/L while on ESA therapy.
Signs and symptoms of serious cardiovascular events may include, but are
not limited to:
- chest pain
- leg pain and swelling
- shortness of breath
- sudden weakness, numbing or tingling of face, arm or leg
- severe sudden headache, loss of vision, or loss of speech
Patients experiencing these signs or symptoms should contact their doctor
immediately. Patients should NOT discontinue their medication without
consulting their doctor first.
A copy of the Health Care Professional letter and this communication are
available on the Health Canada website
(http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/2007/index_e.html).
This information is also available at http://www.janssen-ortho.com.
Managing marketed health product-related adverse reactions depends on
health care professionals and consumers reporting them. Reporting rates
determined on the basis of spontaneously reported post-marketing adverse
reactions are generally presumed to underestimate the risks associated with
health product treatments. Any case of heart attack, heart failure, stroke or
blood clots or other serious or unexpected adverse reactions in patients
receiving Aranesp(R) or EPREX should be reported to Amgen Canada (for
Aranesp(R)), Janssen-Ortho Inc (for EPREX) or Health Canada at the following
addresses:
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Aranesp(R)
Amgen Canada, Inc.
6755 Mississauga Road, Suite 400
Mississauga, Ontario L5N 7Y2
Tel: (866) 502-6436
Fax: (888) 264-3655
safetycanada@amgen.com
EPREX
Janssen-Ortho Inc.
19 Green Belt Drive
Toronto, ON M3C 1L9
Tel: (800) 567-3331
Fax: (866) 767-5865
dsscan@joica.jnj.com
Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may
call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
The AR Reporting Form and the AR Guidelines can be found on the Health
Canada web site or in The Canadian Compendium of Pharmaceuticals and
Specialties.
http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/form/ar-
ei_form_e.html
http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/guide/ar-ei_guid
e-ldir_e.html
For other inquiries related to this communication, please contact Health
Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: mhpd_dpsc@hc-sc.gc.ca
Tel: (613) 954-6522
Fax: (613) 952-7738
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Sincerely,
(signed) (signed)
David N. Churchill, MD, FRCPC Cathy Lau, PhD.
Medical Director, Nephrology Vice President
AMGEN Canada Inc. Regulatory and Quality
Janssen-Ortho Inc.
(*) All trademark rights used under license.